The pelvic floor is a group of muscles, ligaments and connective tissues that together support the pelvic organs. In women, the pelvic floor muscles form a supportive sheet to keep the bladder, the rectum and the uterus in place. These muscles are attached to the fixed framework of the pelvic bones.
Pelvic organ prolapse or POP occurs when the pelvic floor muscles are weakened thereby allowing one or more of these pelvic organs to push against the weakened wall of the vagina. POP, although not usually life threatening, affects urinary, sexual, and colorectal functions. For women with significant complaints, the management of POP currently consists of use of surgical reconstruction or vaginal pessaries.
Vaginal pessaries (i.e., plastic or silicone devices that are inserted into the vagina to help support the vaginal walls and pelvic organs) are used for POP reduction in women who prefer conservative treatment. Periodic removal of these devices, however, is necessary to maintain good hygiene and to reduce or eliminate complications caused at least in part by the prolonged presence of these devices in the vagina, such complications including irritation, erosion, bleeding and malodorous discharge. Ideally, pessaries should be removed on a daily basis.
Unfortunately, a majority of prior art pessaries must be manually squeezed or bent in order to be inserted or removed from the body, thus making self-insertion almost impossible, especially for older women. In fact, only about 5% of patients are able to remove and reinsert their own pessaries, with the majority of patients forced to rely on lifelong regular office visits every two to three months, with each visit including removal, cleaning and reinsertion of the pessary along with a thorough inspection of the vagina. Even in the most experienced hands, removal is very difficult, and sometimes inhumane by today's standards. Most of the time, patients leave the office with small but painful abrasions of the vaginal introitus. This stressful experience is the main reason for pessary discontinuation, and consideration of a reconstructive surgical procedure.
In view of the above, it is a general object of the present invention to provide a vaginal pessary that avoids the drawbacks associated with these prior art pessaries.
It is a more particular object to provide a vaginal pessary that: (a) is easy for a patient to insert and remove from the vaginal cavity; (b) remains firmly anchored in the vaginal cavity during movement, such as coughing, sneezing, laughing, or during exercise; and (c) more effectively controls POP, whether in the form of cystoceles (herniation of the urinary bladder through the wall of the vagina), rectoceles (herniation of the rectum into the vagina), uterine prolapse, and/or vaginal prolapse.
It is another more particular object to provide different embodiments of the inventive vaginal pessary, all of which satisfy the objects identified above.
The present invention therefore provides a compactable vaginal pessary that easily expands once inside a patient's vagina, that can be removed, cleaned and reinserted daily, or as needed, by the patient.
In a first embodiment, the vaginal pessary of the present invention basically comprises: (a) an expandable and collapsible frame member; (b) optionally, a protective cover or sleeve for partially encasing the frame member; and (c) means for (i) expanding the frame member, (ii) retaining the frame member in an expanded configuration, and (iii) collapsing the expanded frame member.
When the frame member is in a collapsed state, the pessary may be easily inserted into the vagina. Once in place, the frame member is expanded, and prior to removal of the pessary, the frame member is returned to a collapsed state.
In a second embodiment, the inventive vaginal pessary basically comprises: (a) an open, substantially cone-shaped, collapsible frame member, the frame member being biased to an open position and comprising a central hub, and a plurality of flexible and resilient spokes emanating from the central hub; (b) a flexible and resilient sheet-like material connecting the spokes of the frame member; and (c) withdrawal means attached to the central hub of the frame member.
The frame member is collapsed prior to insertion of the pessary into the vagina, and once in place in the vagina, the frame member is allowed to adopt an open, substantially conical configuration. Prior to removal of the pessary, the frame member is returned to a collapsed configuration.
In a third embodiment, the inventive vaginal pessary is a yieldably extensible, self-retracting pessary that basically comprises: (a) an elongate cylindrical body having a distal end and a proximal end; (b) optionally, a protective cover or sleeve for encasing the elongate cylindrical body; and (c) withdrawal means attached to the proximal end of the elongate cylindrical body. Prior to insertion into the vagina, the pessary is straightened and, upon proper placement in the vagina, is allowed to adopt a coiled configuration.
Other features and advantages of the invention will be apparent to one of ordinary skill from the following detailed description and accompanying drawings. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. All publications, patent applications, patents and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.